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Solum IV ® is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. The product is indicated to be gently packed into bony voids or gaps in the skeletal system (i.e., extremities and pelvis) in conjunction with an equal volume of bone marrow aspirate. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.

Solum IV ® is a resorbable porous calcium phosphate bone void filler mixed with a porcine gelatin based carrier. It is an osteoconductive implant with a multidimensional porosity similar to human cancellous bone and acts as a scaffold for the in-growth of new bone.It is provided sterile in various configurations within a double sealed package containing a mixing spatula.

Here's an analysis of the provided text regarding the SpineSmith Solum IV® Bone Void Filler, focusing on acceptance criteria, device performance, and the study details.

This document describes a 510(k) submission, which is based on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving direct clinical efficacy through a standalone study with defined acceptance criteria and human expert evaluation in the way a diagnostic AI device would. Therefore, many of the requested points ("Number of experts," "Adjudication method," "MRMC comparative effectiveness study," "Training set sample size," etc.) are not applicable in this context.

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for a 510(k) submission like this are primarily based on demonstrating substantial equivalence to a predicate device. This is achieved by comparing technological characteristics and showing similar (or better) performance in non-clinical testing.

2. Sample Size Used for the Test Set and Data Provenance

The primary "test set" mentioned is an animal study.

• Sample Size: Not explicitly stated (referred to as a "critically sized defect implantation animal study").
• Data Provenance: Not specified, but animal study data typically originates from a controlled laboratory setting. It is inherently prospective in its design for evaluating the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable in the context of this 510(k) submission. The ground truth for the animal study would be established through histological analysis and/or imaging performed by veterinary pathologists or researchers, but the document does not detail this. This is not a study involving human expert interpretation of diagnostic images.

4. Adjudication Method for the Test Set

Not applicable. This is an animal study evaluating bone healing and material resorption, not a diagnostic study requiring human expert adjudication of interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is not an AI/diagnostic imaging device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a bone void filler, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the animal study was likely established through a combination of:

• Histology: Microscopic examination of tissue samples from the implanted defect to assess new bone formation, material resorption, and inflammatory response.
• Radiographic Imaging: X-rays or micro-CT scans to observe bone regeneration.
• Gross Pathology: Macroscopic examination of the defect site.

8. The Sample Size for the Training Set

Not applicable. This device is a bone void filler, not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The device's acceptability and substantial equivalence to the predicate device (nanOss BVF-E, K081558) are primarily established through a non-clinical evaluation, which included:

• Comparative Analysis of Technological Characteristics: A direct comparison of Solum IV's material composition, particle size, Ca/P ratio, porosity, and crystalline structure to the predicate device. The results demonstrated comparable characteristics, with Solum IV showing slightly higher porosity (80% vs 71%), which is generally considered beneficial for osteoconductivity.
• Non-Clinical Testing: This encompassed a range of tests including chemical, physical, and component biocompatibility testing.
• Animal Study: A "critically sized defect implantation animal study" was conducted. This study's purpose was to evaluate the in vivo performance of Solum IV. The conclusion drawn from this study was that Solum IV performed as well as the predicate device. This indicates similar biological integration, resorption, and bone regeneration profiles to the already cleared device.

The totality of this evidence demonstrated to the FDA that Solum IV has similar technological characteristics, intended use, and in vivo performance to the predicate device, thus supporting a determination of substantial equivalence and market clearance.

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